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Assessment of the glucagon receptor blocker REMD-477 on insulin requirements in type 1 diabetes

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R42DK108305-02
Agency Tracking Number: R42DK108305
Amount: $1,429,002.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIDDK
Solicitation Number: PA14-072
Solicitation Year: 2014
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-07-01
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Camarillo, CA 93012-8529
United States
DUNS: 079423227
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (314) 362-8708
Business Contact
Phone: (805) 987-0600
Research Institution
CAMPUS BOX 1054 1 Brookings Drive
SAINT LOUIS, MO 63130-4862
United States

 Nonprofit College or University

DESCRIPTIONprovided by applicantFast TrackInsulin remains the primaryand often the onlytreatment for typediabetes mellitusT DHowever it is associated with chronic iatrogenic hyperinsulinemiasecondary hyperlipidemiahigher incidence and severity of cardiovascular complicationsand life threatening hypoglycemia eventsA higher mortalityvsdue to cardiovascular complications were reported in insulin treated T D patientsversus the general publicAn effective add on therapy is needed to reduce daily insulin doses and to minimize its complicationsREMDis a fully humanhigh affinityglucagon receptorGCGRantibodythat blocks the hepatic GCGR and reduces hepatic glucose ketone productionREMDrestores euglycemia in animal models of typediabetes mellitusT Dand shows preliminary but promising glucose lowering effect in a few T D mouse modelsREMDdemonstrated a benign safety profile in animalsand in healthy volunteers in a first inhuman studySince the overactive glucagon action is a common finding in both T D and T Da robust GCGR blockersuch as REMDrepresents a promising novel strategyIn Phase I of this projectthe glucose lowering effects of REMDwill be thoroughly evaluated inanimal models of T Dincluding a chemicalstreptozotocininduced model in ratsand an autoimmunenon obese diabeticNODmodel in miceboth without insulin treatmentThe animal studies will be directed by DrRoger Ungerat the Touchstone Diabetes CenterUniversity of Texas Southwestern Medical CenterDallasTXIn Phase IIa randomizeddouble blindvehicle controlleddayin patientclinical study will be conducted ipatients with T Dto quantitatively assess the reduction in insulin requirements while maintaining standardized postprandial and postabsorptive glycemic controlThe study will be directed by DrSam KleinChiefDivof Geriatrics and Nutritional Sciencesat the Washing University School of MedicineStLouisMOThe small businessREMD Incprovides research materialsperforms the hormone and metabolite assaysand coordinates the overall project management and supportive dutiesfor both Phase I and II of this projectREMDis projected to be an add on therapy for T DMto substantiallyrtreduce insulin daily dosesleading to better glucose controlfewer and milder complicationsand an improved quality of life

* Information listed above is at the time of submission. *

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